Effect of addition of pemafibrate and double dose of statin on small dense LDL cholesterol in statin-treated patients with type 2 diabetes and hypertriglyceridemia: A comparative Study.

Effect of addition of pemafibrate and double dose of statin on small dense LDL cholesterol in statin-treated patients with type 2 diabetes and hypertriglyceridemia: A comparative Study. - PRESTIGE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190232

Enrollment

102

Registered

2020-02-28

Start date

2020-03-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Interventions

After obtaining informed consent, patients with type 2 diabetes occurring with hypertriglyceridemia who have been taking statin for 3 months or more are randomly allocated to either group receiving pe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age>=20 years old 2. Type 2 diabetes patients 3. Patients who have been taking below statins for 3 months or longer without changing Atorvastatin 5, 10 mg/day Pitavastatin 1, 2 mg/day Rosuvastatin 2.5 mg/day 4. 150mg/dL=<TG<500mg/dL within three months prior to informed consent 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes patients 2. 160mg/dL==10% within three months prior to informed consent 5. familial hypercholesteremia 6. Patients taking statins other than those specified in the inclusion criteria 7. Patients taking statins other than those prescribed by the inclusion criteria 8. Patients who have taken SPPARM alpha or fibrates within three months prior to informed consent 9. Patients who have changed prescriptions for dyslipidemia * and diabetes within three months prior to informed consent 10. Patients receiving pemafibrate 11. 1.5mg/dL=<serum creatinine 12. Alcoholics patients (or alcohol abuse patients) 13. Patients who have developed diabetic ketoacidosis within three months prior to informed consent 14. Patients with active malignant tumor, autoimmune disease, infectious disease 15. Any other patients regarded unsuitable by the principal investigator or sub-investigators

Design outcomes

Primary

Measure	Time frame
sd LDL-C reduction rate	—

Secondary

Measure	Time frame
Absolute concentration and reduction rate of each item 1. sd LDL-C(Absolute concentration onlys) 2. Large LDL-C 3. LDL-C 4. HDL fractionation 5. sd LDL-C / Large LDL-C 6. LDL-TG, LDL-TG/LDL-C 7. TG, HDL-C 8. Non-HDL-C 9. RLP-C 10. Toxic-AGEs 11. VLDL-C (a formula) 12. ANGPTL2, ANGPTL3, ANGPTL4, ANGPTL8 13. Apo A1, Apo A2, Apo B, Apo CII, Apo CIII, Apo E 14. High sensitivity CRP 15. AST, ALT, gamma-GTP, ALP, CK, Creatinine 16. Blood sugar, insulin, HOMA-IR 17. eGFR 18. FIB-4 index 19. Cholinesterase 20. HbA1c, Glycoalbumin 21. HbA1c/Glycoalbumin 22. Urine Albumin-to-Creatinine Ratio	—

Measure

Time frame

Absolute concentration and reduction rate of each item 1. sd LDL-C(Absolute concentration onlys) 2. Large LDL-C 3. LDL-C 4. HDL fractionation 5. sd LDL-C / Large LDL-C 6. LDL-TG, LDL-TG/LDL-C 7. TG, HDL-C 8. Non-HDL-C 9. RLP-C 10. Toxic-AGEs 11. VLDL-C (a formula) 12. ANGPTL2, ANGPTL3, ANGPTL4, ANGPTL8 13. Apo A1, Apo A2, Apo B, Apo CII, Apo CIII, Apo E 14. High sensitivity CRP 15. AST, ALT, gamma-GTP, ALP, CK, Creatinine 16. Blood sugar, insulin, HOMA-IR 17. eGFR 18. FIB-4 index 19. Cholinesterase 20. HbA1c, Glycoalbumin 21. HbA1c/Glycoalbumin 22. Urine Albumin-to-Creatinine Ratio

—

Contacts

Public ContactYusaku Mori

Showa University Hospital

u-mori@med.showa-u.ac.jp+81-3-3784-8947

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026